RADIANCE Radiochemotherapy +/- Durvalumab for locally-advanced Anal Carcinoma; A multicenter, randomized, phase II trial of the German Anal Cancer Study Group
The RADIANCE trial is looking at new ways to treat locally advanced anal cancer (stages 2 and 3). The usual treatment is chemoradiotherapy, which combines chemotherapy drugs with radiotherapy beams aimed at the cancer. In this study, researchers want to find out if adding an immunotherapy drug called durvalumab (also known as IMFINZI) improves results. Immunotherapy works by helping your body's natural immune system spot and destroy cancer cells. Half of the people in the study will receive standard chemoradiotherapy alone, while the other half will receive chemoradiotherapy plus durvalumab infusions. Doctors will closely track how well the tumour shrinks, whether patients can avoid needing a permanent stoma bag (colostomy), and how the treatment affects everyday quality of life over time.
At a glance
What is this study about?
Anal cancer is a condition where abnormal cells grow in the tissues of the anus. When the cancer is 'locally advanced' (often classified as stage 2 or stage 3), it means the tumour has grown larger or spread to nearby lymph nodes, but has not spread to distant parts of the body. Currently, the most effective standard treatment is chemoradiotherapy. This uses a combination of chemotherapy medicines and radiotherapy beams to destroy the cancer cells while trying to keep the bowel working normally.
While standard chemoradiotherapy works well for many people, the cancer can sometimes come back, or patients may experience difficult side effects. In some cases, people might eventually need surgery to remove the bowel and create a stoma (an opening on the abdomen for waste). Researchers are constantly looking for ways to improve cure rates, reduce the need for stoma surgery, and protect long-term quality of life.
The RADIANCE trial is exploring whether adding a medicine called durvalumab can make standard treatment more effective. Durvalumab is an immunotherapy drug that works by 'unmasking' cancer cells, making it easier for your own immune system to attack them. By testing this approach in a phase 2 clinical trial, researchers hope to discover if combining immunotherapy with chemoradiotherapy helps clear the cancer more completely and keeps it from returning.
Taking part in research like this helps doctors learn whether new treatment combinations are safe and worthwhile. The findings from this study could help shape future guidelines for anal cancer care across the UK and internationally.
Key takeaways
- The RADIANCE trial tests if adding immunotherapy (durvalumab) to standard treatment improves outcomes for stage 2 and 3 anal cancer.
- Participants will receive standard chemoradiotherapy, either with or without durvalumab infusions.
- Researchers want to see if the combination keeps cancer away for longer and reduces the need for permanent stoma surgery.
- The study includes adults aged 18 and over who have locally advanced anal cancer.
- Taking part is completely voluntary, and you can stop participating at any point.
Who may be eligible?
This trial is open to adults aged 18 and older of any sex who have been diagnosed with locally advanced anal cancer, specifically stage 2 or stage 3. The cancer must not have spread to distant organs such as the liver or lungs.
Because this study involves intensive cancer treatments, participants generally need to be well enough to manage day-to-day activities and tolerate chemotherapy and radiotherapy. Your hospital team will perform checks, such as blood tests and heart scans, to ensure your body can safely handle the medications.
You might not be able to take part if you have already had certain treatments for anal cancer, if you have severe auto-immune conditions, or if you have other serious medical issues that could make the trial medicines unsafe. Your specialist doctor will look at your full medical history to confirm whether the study is a good match for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- I have been diagnosed with stage 2 or stage 3 anal cancer.
- My cancer has not spread to distant parts of my body (such as my liver or lungs).
- I am currently fit enough to undergo chemotherapy and radiotherapy.
- I have discussed my diagnosis and available clinical trials with my cancer care team.
What does participation involve?
If you decide to take part, you will first have screening tests, such as blood samples, physical checks, and imaging scans (like an MRI). Because this is a randomised study, a computer will assign you by chance to one of two groups: one group receives standard chemoradiotherapy alone, and the other receives standard chemoradiotherapy alongside the study medicine, durvalumab.
Durvalumab is given as a liquid through a drip directly into a vein (an intravenous infusion) at the hospital. Radiotherapy is usually given in short daily hospital visits over several weeks, alongside planned chemotherapy doses. Around 26 weeks after starting, your team will carry out an MRI scan and a camera examination of the back passage (proctoscopy) to see how well the cancer has responded.
After your treatment ends, you will have regular follow-up clinic visits. During these checks, doctors will monitor your health, carry out routine scans, and ask you to fill out short surveys about your general well-being and bowel function. In total, follow-up can continue for several years to track long-term recovery.
Potential risks and benefits
Locations (2)
- —UnverifiedAustria
- —UnverifiedGermany
Common questions
What is durvalumab and how does it work?
Durvalumab is an immunotherapy medicine. It blocks a specific protein that cancer cells use to hide from your body's immune system, allowing your white blood cells to recognise and attack the tumour.
Will I definitely get the new medicine?
No. This is a randomised trial, meaning a computer randomly decides whether you receive standard chemoradiotherapy on its own or with durvalumab. This ensures the comparison between treatments is fair.
What does having a stoma mean?
A stoma is an opening made on the abdomen that allows waste to leave the body into a secure bag. One of the main goals of this study is to see if better treatments can help people avoid needing a permanent stoma.
Do I have to pay to take part in this trial?
No. In the UK, clinical trial treatments, standard tests, and hospital appointments are provided through the NHS at no cost to you.
What happens if I change my mind after starting?
You are free to leave the trial whenever you want. You do not need to give a reason, and stepping down will never harm your relationship with your medical team or your standard care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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